Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

B-SCAN 10 MHZ PROBE

K-Number: K896038 · 1990-04-23

ApplicantTeknar, Inc.
Decision Date1990-04-23
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

B-SCAN 10 MHZ PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Teknar, Inc.. It received FDA 510(k) clearance on 1990-04-23 under 510(k) number K896038. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-SCAN 10 MHZ PROBE?

B-SCAN 10 MHZ PROBE is a medical device that received FDA 510(k) clearance on 1990-04-23. The listed applicant is Teknar, Inc.. The 510(k) number is K896038.

When did B-SCAN 10 MHZ PROBE receive FDA 510(k) clearance?

B-SCAN 10 MHZ PROBE received FDA 510(k) clearance on 1990-04-23, under 510(k) number K896038.

Who is the listed applicant for B-SCAN 10 MHZ PROBE?

The FDA 510(k) record lists Teknar, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-SCAN 10 MHZ PROBE?

The FDA product code for B-SCAN 10 MHZ PROBE is ITX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Teknar, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K903666OPHTHASONIC A/P IIIK896150IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONICK891777PRO-CUT BIOPSY NEEDLEK883965PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTORK881850TEKNAR PERCU-SCANK881605BIOPSY GUIDE

View all 18 devices →

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑